This invention relates generally to the field of surgical devices and more specifically to an apparatus for repositioning the vagina, cervix, uterus and pelvic floor and method for securing same.
Women may have weakened or damaged pelvic floor muscles, connective tissue, ligaments and skin, often related to past pregnancy and childbirth or genetic factors. The weakened or damaged connective tissue, muscles and ligaments fail to provide adequate support to the vagina, cervix, uterus and pelvic floor, which may lead to excessive movement of these structures and a falling away from their normal position in the body in a condition called uterovaginal prolapse or pelvic prolapse, causing symptoms and dysfunction of the related organs. One type of prolapse of the vagina and pelvic floor may involve a weakened anterior vaginal portion, which normally supports the bladder, causing the anterior vaginal wall, bladder and ureters to be displaced downward toward, or out through, the vaginal opening. Another type of prolapse involves the apical portion, which is the deepest “inside” or top portion of the vagina, and the cervix with uterus, if present. Many women may have previously had a hysterectomy, with removal of the uterus and/or cervix, which predisposes them to vaginal prolapse. The apical portion of the vagina, with uterus and cervix, if present, may descend toward or out through the vaginal opening. Another type of prolapse involves the posterior vaginal wall and rectum, which may descend downward toward, or out through, the vaginal opening. Another type of prolapse involves the perineal body, a pyramid-shaped structure between the most distal portion of the vagina and anus, which may become weakened and detached from its supporting connective tissue, muscles, ligaments, or skin, resulting in excessive movement of the perineal body and entire pelvic floor. Each of these types of prolapse may occur singly or together in any combination.
Pelvic floor prolapse can be corrected with certain types of surgery, such as vaginal procedures, open abdominal (laparotomy), or “closed” abdominal laparoscopic techniques. In the early twentieth century, repair of the anterior vaginal compartment (anterior colporrhaphy for repair of cystocele) and/or repair of the posterior vaginal compartment (posterior colporrhaphy for repair of rectocele) were offered to women with prolapse in these areas. The repair procedures comprised techniques performed through the vaginal opening, which resulted in a reduction in excess vaginal length and girth. High rates of recurrence and disabling prolapse, pain or scarring sometimes followed these procedures. In 1957, surgeons began attaching the uterus to the anterior longitudinal ligament as a more durable technique. In 1962, Lane first described the use of a bridging material, or graft, to attach the vagina and cervix to the sacrum via an open abdominal, or laparotomy procedure, to support the apical compartment of the vagina. Slow recovery and morbidity often followed as a result of the large abdominal incision for this procedure.
With advances in surgical equipment and technique, many of these repairs are now performed laparoscopically, utilizing several small incisions in the abdominal wall. The surgical treatment usually involves a technique where the surgeon attaches the cervix, vagina, and/or perineal body muscles and connective tissue via a graft material to the strong ligamentous structure overlying the sacral promontory at the base of the spine. The procedure is termed sacrocolpopexy.
A vaginal manipulator device which became available around 2010 as described in the U.S. Patent Application Publication No. 2012/0016185 A1 has a number of deficiencies. First, the manipulator tip intravaginal portion is straight along its long axis which often does not allow adequate exposure for surgical dissection and placement of sutures for the anterior wall under the bladder, or for the posterior vaginal wall, extending down to the perineal body and pelvic floor, which is the optimal technique. The optional external curved handle, or other available handles, do not compensate for this deficiency, and therefore this tip compromises the surgical technique, safety and efficiency of the sacrocolpopexy procedure. Secondly, although the distal tip portion of the vaginal manipulator can have a recess for the cervix to be received, or other annular, bladed-type systems as described, none of these provide for the cervix to be repositioned in an anterior or posterior orientation, and therefore do not allow for cystocele and/or rectocele reduction by shortening of the anterior or posterior vaginal wall by such a maneuver. Furthermore, the vaginal manipulator device does not limit the insertion depth into the vagina, nor does it facilitate proper tensioning of these tissues, oftentimes subjecting the vaginal walls and tissues to injury or breakage during the performance of the procedure due to this deficiency, which exposes the patient to markedly increased risk for infection, mesh exposure, poor wound healing and the need for future additional surgical procedures.